Clinical Investigation of the Next-Generation Intraocular Lenses

Cataract Clinical Trial

Official title:

Clinical Investigation of the TECNIS Next-Generation Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372434
• Other study ID #: SUR-CAT-652-1001
• Status: Completed
• Phase: N/A
• Start date: January 16, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: July 2021
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a 6-month, prospective, multicenter, subject/evaluator-masked, bilateral, randomized clinical investigation of the TECNIS Next-Generation Model ZFR00 and Model ZYR00 IOLs versus the TECNIS Multifocal Model ZLB00 control IOL.

The study will be conducted at up to 14 sites in the U.S.A and will enroll up to 260 subjects to achieve approximately 220 randomized and bilaterally-implanted subjects, resulting in approximately 195 evaluable subjects (65 in each test group and 65 in the control group) at 1 and 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZFR00 IOL, the ZYR00 IOL or the ZLB00 control IOL. The eye implanted first will be considered the primary study eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: October 30, 2018
• Est. primary completion date: July 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Minimum 22 years of age

• Bilateral cataracts for which posterior chamber IOL implantation has been planned

• Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with a glare source or 20/40 Snellen or worse without a glare source

• Potential for postoperative BCDVA of 20/30 Snellen or better

• Corneal astigmatism:

• Normal corneal topography

• Preoperative corneal astigmatism of 1.00 D or less in both eyes

• Clear intraocular media other than cataract in each eye

• Availability, willingness and sufficient cognitive awareness to comply with examination procedures

• Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries

• Ability to understand and respond to a questionnaire in English

Exclusion Criteria:

• Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D

• Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils)

• Irregular corneal astigmatism

• Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)

• Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery. Note:

Prophylactic peripheral iridotomies and peripheral laser retinal repairs that, in the opinion of the investigator will not confound study outcome or increase risk to the subject, are acceptable.

• Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study

• Inability to achieve keratometric stability for contact lens wearers (per procedure outlined in Section 10.3)

• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject

• Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study

• Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects

• Use of systemic or ocular medications that may affect vision

• Prior, current, or anticipated use during the course of the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)

• Poorly-controlled diabetes

• Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.

• Known ocular disease or pathology that, in the opinion of the investigator,

• may affect visual acuity

• may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.)

• may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)

• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes

• Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial

• Desire for monovision correction

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Investigational Intraocular Lens Device #1: Model ZFR00
IOL replaces the natural lens removed during cataract surgery.
• Investigational Intraocular Lens Device #1: Model ZYR00
IOL replaces the natural lens removed during cataract surgery.
• TECNIS Multifocal Intraocular Lens: Model ZLB00
IOL replaces the natural lens removed during cataract surgery.

Locations

Country	Name	City	State
United States	Chesapeake Eye Care & Laser Center	Annapolis	Maryland
United States	Empire Eye & Laser Center	Bakersfield	California
United States	Katzen Eye Care and Laser Center	Boynton Beach	Florida
United States	Eye Doctors of Washington	Chevy Chase	Maryland
United States	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania
United States	Loden Vision Centers	Goodlettsville	Tennessee
United States	Texas Eye and Laser Center	Hurst	Texas
United States	Clarus Eye Centre	Lacey	Washington
United States	Eye Specialty Group	Memphis	Tennessee
United States	Carolina EyeCare Physicians, LLC	Mount Pleasant	South Carolina
United States	Lehmann Eye Center	Nacogdoches	Texas
United States	Focal Point Vision	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance Corrected Intermediate Visual Acuity	Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.	1 month